Comparison of Treatment Response to Intravitreal Injection of Combined Propranolol and Bevacizumab Versus Bevacizumab Monotherapy in Patients With Wet Age Related Macular Degeneration :A Clinical Trial

• Status: Unknown status
• Trial end date: 2019-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to compare the effect of combined intravitreal Bevacizumab and Propranolol injection versus Bevacizumab monotherapy in patients with Age Related Macular Degeneration.

Methods:

In this study patients with Age Related Macular Degeneration who are naïve or had history of previous treatment are included. The eligible patients in randomized in two groups "Bevacizumab" and "Bavacizumab + propranolol" and in injected intravitreally for 3 times monthly. In "Bevacizumab+propranolol" group patients receive two injections at each session Bavacizumab and propranolol. In "Bevacizumab" group patients receive only Bevacizumab. The patients are followed for 6 months and central macular thickness and visual acuity is measured at baseline and monthly for 6 month. Baseline ancillary exams include Fluorescein Angiography and OCT-Angiography which is performed at the final exam as well. Patients needing any therapeutic intervention is addressed during the 6 month follow up period.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Shahid Beheshti University of Medical Sciences
• Treatments: Bevacizumab; Propranolol

Criteria

Inclusion Criteria:

• Patients with Wet AMD and Vision less than 20/40

Exclusion Criteria:

• History of cardiac ,renal, respiratory diseases (due to beta blocker toxicity),

• Associated with other Macular abnormalities such as Diabetic Retinopathy, Macular traction

• History of ocular inflammation

• Subretinal fibrosis

• History of Cataract surgey less than 6 months

• History of Glaucoma Surgery ,Vitreoretinal surgery

• Media opacity